Specialty drugmaker BioSante
BioSante has experienced many ups and downs over the years. It had a "promising" (ahem) AIDS vaccine and travails with allegedly dishonest former leader Avi Ben-Abraham. The announcement of the start of phase 3 testing for LibiGel is BioSante's latest attempt at developing a drug to treat a potentially large patient population ... but there are a few catches.
LibiGel is a testosterone gel BioSante advanced into phase 3 testing earlier in the month. It's the first of three clinical trials that could support an FDA marketing application in around two years (by my estimate). Even if the FDA allows LibiGel onto the market -- and that's a big if -- there are already a ton of similar generic products on the market. Patients don't have to be Barry Bonds or Roger Clemens to get access to testosterone gels, injections, creams, patches, and pills.
If LibiGel or a rival testosterone patch from Procter & Gamble
A similar fate may await BioSante's recently approved estrogen gel, Elestrin. Like testosterone replacement drugs, Elestrin resembles dozens of estradiol compounds on the market. In the third quarter, BioSante's marketing partner for Elestrin, Bradley Pharmaceuticals
Even though LibiGel won't be a generic, it will be competing against plenty of them. The drug could become a low-margin, sub-$100 million treatment, like Novartis'
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